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AstraZeneca

Clomicalm
Clomipramine


PACKAGE LEAFLET:


Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs


  1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT


    Marketing authorisation holder and manufacturer responsible for batch release: VIRBAC

    1ère avenue – 2065 m – LID 06516 Carros

    France


  2. NAME OF THE VETERINARY MEDICINAL PRODUCT


    Clomicalm 5 mg tablets for dogs Clomicalm 20 mg tablets for dogs Clomicalm 80 mg tablets for dogs


    Clomipramine hydrochloride


  3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)


    5 mg Clomipramine hydrochloride (equivalent to 4.5 mg Clomipramine) 20 mg Clomipramine hydrochloride (equivalent to 17.9 mg Clomipramine) 80 mg Clomipramine hydrochloride(equivalent to 71.7 mg Clomipramine)


    5 mg tablet: Brownish-grey, oval-oblong, divisible. Scored on both sides.


    20 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears the imprint ‘C/G’, the other ‘G/N’ and scored on both sides.


    80 mg tablet: Brownish-grey, oval-oblong, divisible. One side bears the imprint ‘I/I’, the other no imprint and scored on both sides.


  4. INDICATION(S)


    As an aid in the treatment of separation related disorders manifested by destruction and inappropriate elimination (defaecation and urination) and only in combination with behavioural modification techniques.


  5. CONTRAINDICATIONS


    Do not use in case of known hypersensitivity to clomipramine and related tricyclic antidepressants. Do not use in male breeding dogs.


  6. ADVERSE REACTIONS

    Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued. Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolized via the hepatic system. Vomiting may be reduced by co-administration with a small quantity of food.


    The frequency of adverse reactions is defined using the following convention:

    • very common (more than 1 in 10 animals treated displaying adverse reaction(s))

    • common (more than 1 but less than 10 animals in 100 animals treated )

    • uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

    • rare (more than 1 but less than 10 animals in 10,000 animals treated )

    • very rare (less than 1 animal in 10,000 animals treated, including isolated reports)


      If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.


  7. TARGET SPECIES


    Dog


  8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION


    Clomicalm is administered twice daily at a dose of 1-2 mg/kg clomipramine to give a total daily dose of 2-4 mg/kg according to the following table:


    Body weight

    Clomicalm 5 mg

    Clomicalm 20 mg

    Clomicalm 80 mg

    1.25 - 2.5 kg

    ½ tablet

    ---

    ---

    >2.5 - 5 kg

    1 tablet

    ---

    ---

    >5 - 10 kg

    ---

    ½ tablet

    ---

    >10 - 20 kg

    ---

    1 tablet

    ---

    >20 - 40 kg

    ---

    ---

    ½ tablet

    >40 - 80 kg

    ---

    ---

    1 tablet


    Clomicalm may be given orally with or without food.


  9. ADVICE ON CORRECT ADMINISTRATION


    In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders. Some cases may require longer treatment. In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.


  10. WITHDRAWAL PERIOD(S)


    Not applicable


  11. SPECIAL STORAGE PRECAUTIONS


    Store in the original container. Keep out of sight and reach of children as accidental ingestion should be regarded as serious.

    Do not use after the expiry date which is stated on the label after EXP.

  12. SPECIAL WARNING(S)


    Special warnings for each target species It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit risk ratio. Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention. Clomicalm should be used under veterinary supervision. The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25 kg or under six months of age.


    Special precautions to be taken by the person administering the veterinary medicinal product to animals: In children, accidental ingestion should be regarded as serious. There is no specific antidote. In case of accidental ingestion, seek medical advice immediately and show the product label to the physician. Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.


    Pregnancy and lactation:The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation. Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.


    Interaction with other medicinal products and other forms of interaction: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs. Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives. The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors. Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine. Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.


    Overdose (symptoms, emergency procedures, antidotes):At overdose with 20 mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing. Overdose with 40 mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs. Higher doses (500 mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness. Still higher doses (725 mg/kg) produced, in addition, convulsions and death.


  13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY


    Any unused veterinary medicinal product or waste materials derived form such veterinary medicinal products should be disposed of in accordance with local requirements.


  14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED



  15. OTHER INFORMATION


For animal treatment only.

Pack size: 30 tablets


For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.


België/Belgique/Belgien

VIRBAC BELGIUM NV

Esperantolaan 4 BE-3001 Leuven

Tél/Tel : +32-(0)16 387 260

info@virbac.be

Lietuva

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Prancūzija

Tel: +33-(0)4 92 08 73 00


Република България

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros Франция

Teл: +33-(0)4 92 08 73 00

Luxembourg/Luxemburg

VIRBAC BELGIUM NV

Esperantolaan 4 BE-3001 Leuven Belgique / Belgien

Tél/Tel: +32-(0)16 387 260


Česká republika

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francie

Tel: +33-(0)4 92 08 73 00

Magyarország

VIRBAC HUNGARY KFT

Szent Istvàn krt.11.II/21. HU-1055 Budapest

Tel: +36703387177


Danmark

VIRBAC Danmark A/S

Profilvej 1

DK-6000 Kolding Tlf: +45 75521244

Malta

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Franza

Tel: + 33-(0)4 92 08 73 00


Deutschland

VIRBAC Tierarzneimittel GmbH Rögen 20

DE-23843 Bad Oldesloe Tel: +49-(4531) 805 111

Nederland

VIRBAC Nederland BV Hermesweg 15

NL-3771 ND-Barneveld Tel : +31-(0)342 427 127

info@virbac.nl


Eesti

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Prantsusmaa

Tel: +33-(0)4 92 08 73 00

Norge

VIRBAC Danmark A/S Profilvej 1

DK-6000 Kolding

Danmark

Tel: + 45 75521244


Ελλάδα

VIRBAC HELLAS Α.Ε.

13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση

Τηλ: +30 2106219520

Österreich

VIRBAC Österreich GmbH

Hildebrandgasse 27 A-1180 Wien

Tel: +43-(0)1 21 834 260

España

VIRBAC ESPAÑA SA

Angel Guimerá 179-181

ES-08950 Esplugues de Llobregat (Barcelona)

Tel. : + 34-(0)93 470 79 40

Polska

VIRBAC Sp. z o.o.

ul. Puławska 314

PL 02-819 Warszawa

Tel.: + 48 22 855 40 46


France VIRBAC France 13e rue LID

FR-06517 Carros

Tél : +33-(0)805 05 55 55

Portugal

VIRBAC de Portugal Laboratórios LDA R.do Centro Empresarial

Ed13-Piso 1- Esc.3 Quinta da Beloura PT-2710-693 Sintra

Tel: + 351 219 245 020


Hrvatska

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francuska

Tel: + 33-(0)4 92 08 73 00

România

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Franţa

Tel: + 33-(0)4 92 08 73 00


Ireland

VIRBAC

1ère avenue 2065m LID FR-06516 Carros

France

Tel: + 33-(0)4 92 08 73 00

Slovenija

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francija

Tel : + 33-(0)4 92 08 73 00


Ísland

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Frakkland

Sími: + 33-(0)4 92 08 73 00

Slovenská republika

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francúzsko

Tel: + 33-(0)4 92 08 73 00


Italia

VIRBAC SRL

Via Ettore Bugatti, 15 IT-20142 Milano

Tel: + 39 02 40 92 47 1

Suomi/Finland

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Puh/Tel : + 33-(0)4 92 08 73 00


Κύπρος

VIRBAC HELLAS Α.Ε.

13o χλμ Ε.Ο. Αθηνών - Λαμίας EL-14452, Μεταμόρφωση

Τηλ.: +30 2106219520

Sverige

VIRBAC Danmark A/S Filial Sverige

SE-171 21 Solna

Tel: +45 75521244


Latvija

VIRBAC

1ère avenue 2065 m LID FR-06516 Carros

Francjia

Tel: +33-(0)4 92 08 73 00

United Kingdom (Northern Ireland)

VIRBAC

1ère avenue 2065m LID FR-06516 Carros France

Tel: + 33-(0)4 92 08 73 00